DETAIL OF ACCREDITATION
|
Materials/Products tested |
Type of test/Properties measured/Range of measurement |
Standard specifications/ Equipment/Techniques used |
Location Code |
|
EXTENSIBLE BANDAGES |
Physical Testing Elastic properties |
BS 7505:1995 (on unwashed samples) TM-393 |
A |
|
MEDICAL SPECIMEN CONTAINERS FOR MICROBIOLOGY |
Safety Testing Leak testing |
BS 5213:1975, App A BS EN 14254:2004 anx D TM-18 |
A |
|
COMPRESSION HOSIERY |
Physical Testing |
|
|
|
Measurement of compression profiles |
Documented In-House Method, TM-71, based on BS 6612:1985(1997) & BS 7672:1993 |
A |
|
|
Graduated Compression Hosiery - Compression, stiffness, durability |
BS 6612:1985 (2013) excluding section 5 TM-225 |
A |
|
|
Anti-embolism hosiery - Compression, stiffness, durability |
BS 7672:1993 excluding section 7 TM-241 |
A |
|
|
Support hosiery - Compression, stiffness |
BS 7563:1999 excluding section 6 TM-405 |
A |
|
|
Graduated Compression Hosiery, Anti-Embolism Hosiery and Graduated Support Hosiery – Compression, durability and stiffness |
BS 661210:2018 TM-487 |
A |
|
|
MEDICAL DEVICES (GENERAL) |
Safety testing |
|
|
|
Endotoxin testing by quantitative kinetic turbidimetric method |
British & European Pharmacopoeia Bacterial Endotoxin Test USP Transfusion and Infusion Assemblies and Similar Medical Devices TM-254 including RO water |
A |
|
|
Health and Hygiene |
|
|
|
|
Estimation of bioburden |
BS EN ISO 11737-1:2018 TM-345 |
A |
|
|
VAGINAL SPECULUMS |
Speculum Break Testing |
Documented In-House Method TM-334 |
A |
|
MEDICAL GLOVES |
Perforations Force at Break |
BS EN 455-1:2020 TM-22 BS EN 455-2:2015 TM-342 |
A A |
|
Extractable Protein |
BS EN 455-3:2015 Annx A TM-230 |
A |
|
|
Determination of Removable Surface Powder |
BS EN 455-3:2015 Section 5.2 |
A |
|
|
|
BS EN ISO 21171:2006 TM-391 |
A |
|
|
Endotoxins |
BS EN 455-3:2015 Section 5.1 |
A |
|
|
|
European Pharmacopoeia TM-254 |
A |
|
|
Dimensions |
BS EN 455-2: 2015 TM-343 |
A |
|
|
Labelling |
BS EN 455-2: 2015 & BS EN 455-3:2015 TM-392 |
A |
|
|
WOUND DRESSINGS |
Physical Testing |
|
|
|
Adhesiveness |
BP 1993, Vol 2, App XX H, Test 1 |
A |
|
|
|
BP 1993, Addendum1996, App XX H, Test 1 TM-186 |
A |
|
|
|
BP 1993, Vol 2, App XX H, Test 2 TM-175 |
A |
|
|
Dispersion characteristics |
BS EN 13726-1:2002 Section 3.6 |
A |
|
|
|
BP 1993 Addendum 1995 Alginate Dressing/Packing TM-112 |
A |
|
|
Dispersion/solubility of hydrogel dressings |
BS EN 13726-1:2002 Section 3.7 TM-116 |
A |
|
|
Free swell absorptive capacity |
BS EN 13726-1:2002 Section 3.2 |
A |
|
|
|
BP 1993 Addendum 1995 Alginate Dressing/Packing – Absorbency TM-101 |
A |
|
|
Fluid handling capacity |
BS EN 13726-1:2002 Section 3.3 TM-390 |
A |
|
|
|
BP 1993 Addendum 1996 - Semi-permeable hydrocolloid dressings - Fluid Handling TM-65 |
A |
|
|
Absorbency and fluid retention |
Documented In-House Method TM-404 |
A |
|
|
Absorbency under compression |
Documented In-House Method TM-414 |
A |
|
|
WOUND DRESSINGS (cont’d) |
Physical Testing (cont’d) |
|
|
|
Fluid affinity of amorphous hydrogels |
BS EN 13726-1:2002 Section 3.4 TM-238 |
A |
|
|
Conformability for primary wound dressings |
BS EN 13726-4:2003 TM-396 |
A |
|
|
Moisture vapour transmission of Permeable Film Dressings |
BS EN 13726-2: 2002 TM-394 |
A |
|
|
Moisture Vapour Transmission Rate from Dressings by Electronic Data Capture Method |
Supplemented by Documented In-House Method, TM-8, based on BS EN 13726-2:2002 |
A |
|
|
Waterproofness |
BS EN 13726-3: 2003 TM-395 |
A |
|
|
|
BP 1993, Vol 2, App XX K |
A |
|
|
Biological |
BP 1993, Addendum 1996- App XX K TM-185 |
A |
|
|
Test for Bacterial Penetration of Film Dressings |
Documented In-House Method TM-43 |
A |
|
|
URETHRAL CATHETERS |
Health and Hygiene |
|
|
|
|
Surface finish |
BS EN ISO 20696:2018 Section 5.4 TM-309 |
A |
|
|
Dimensions |
BS EN ISO 20696:2018 Section 5.5 TM-300 |
A |
|
|
Strength |
BS EN ISO 20696:2018 Section 6.1 Annex A TM-301 |
A |
|
|
Connector security |
BS EN ISO 20696:2018 Section 6.2 Annex B TM-302 |
A |
|
|
Occlusion of drainage eyes and leakage from balloons |
BS EN ISO 20696:2018 Section 6.3 Annex C TM-303 |
A |
|
|
Balloon recovery volume |
BS EN ISO 20696:2018 Sections 6.4.2 Annex D TM-304 |
A |
|
URETHRAL CATHETERS |
Flow rate |
BS EN ISO 20696:2018 Section 6.5 Annex E TM-305 |
A |
|
|
Symbols and labelling |
BS EN ISO 20696:2018 Sections 5.5, 7.2, 7.3 TM-308 |
A |
|
URINE COLLECTION BAGS |
Health and Hygiene |
|
|
|
|
Physical, mechanical: Rated and test Volume |
BS EN ISO 8669-2:1997: Section 6.1 TM-286 & TM-297 |
A |
|
|
Freedom from leakage without load |
BS EN ISO 8669-2:1997: Section 6.2 TM-287 |
A |
|
|
Freedom from leakage under load |
BS EN ISO 8669-2:1997: Section 6.3 TM-288 |
A |
|
|
Freedom from leakage under impact |
BS EN ISO 8669-2:1997: Section 6.4 TM-289 |
A |
|
|
Non-return valve |
BS EN ISO 8669-2:1997: Section 6.5 TM-290 |
A |
|
|
Strength of attachment systems of bags provided with cutouts |
BS EN ISO 8669-2:1997: Section 6.6 TM-291 |
A |
|
|
Strength of attachment systems of bags provided with button and buttonhole systems |
BS EN ISO 8669-2:1997: Section 6.7 TM-292 |
A |
|
|
Strength of integral suspensory systems |
BS EN ISO 8669-2:1997: Section 6.8 TM-293 |
A |
|
|
Strength of attachment of the inlet tubing |
BS EN ISO 8669-2:1997: Section 6.9 TM-294 |
A |
|
URINE COLLECTION BAGS |
Pressure/time required to initiate flow into the bags and filling rate |
BS EN ISO 8669-2:1997: Section 6.10 TM-295 |
A |
|
|
Dimensions |
BS EN ISO 8669-2:1997: Annex A TM-296 |
A |
|
CONTROLLED CLEAN ROOMS |
Physical Testing |
|
|
|
Classification of air cleanliness |
BS EN ISO 14644-1:2015 and current GMP guidance TM-266 |
S1 |
|
|
Health and Hygiene |
|
|
|
|
Active air and surface microbiological monitoring |
Documented In-House Method, TM-354, based on current GMP guidance |
S1 |
|
|
FLUIDS |
Total Viable Count by filtration or spread plate method of Fluid Samples (potable and process water, aqueous solutions and liquids or powders reconstituted in water or aqueous diluents only) |
Documented In-House Method, TM-372 |
A |